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Enforcement Report for December 22, 2004

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

_______________________________PRODUCTa) Red Blood Cells, Leukocytes Reduced. Recall # B-0345-5;b) Fresh Frozen Plasma. Recall # B-0346-5;c) Platelets for further manufacture. Recall # B-0347-5.CODEa), b), and c) Unit number 2045871.RECALLING FIRM/MANUFACTURERBlood Bank of Delaware, Inc., aka Blood Bank of Delmarva, Newark, DE, by facsimile on August 9, 2004, and by letter on September 14, 2004. Firm initiated recall is complete.REASONBlood products, that tested negative for viral markers, but were collected from an ineligible donor due to behavior known to increase risk of infection with human immunodeficiency virus (HIV), were distributed.VOLUME OF PRODUCT IN COMMERCE3 units.DISTRIBUTIONDE, and NJ.

_______________________________PRODUCTPlatelets Pheresis, Leukocytes Reduced. Recall # B-0353-5.CODEUnit number 9076067.RECALLING FIRM/MANUFACTURERBlood Bank of Delaware, Inc., aka Blood Bank of Delmarva, Newark, DE, by telephone on July 24, 2004, and by letter on September 7, 2004. Firm initiated recall is complete.REASONBlood product, that was not tested for pH as required by the firm?s specifications, was distributed.VOLUME OF PRODUCT IN COMMERCE1 unit.DISTRIBUTIONDE.

_______________________________PRODUCTPlatelets Pheresis, Leukocytes Reduced. Recall # B-0356-5.CODEUnit number 13P89758.RECALLING FIRM/MANUFACTURERThe American National Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone on July 4, 2004, and by letters dated July 23, 2004, and August 23, 2004. Firm initiated recall is complete.REASONBlood product, that was labeled leukoreduced but was collected on an apheresis device undergoing validation and was not tested to determine the white blood cell count as required in the firm's standard operating procedures, was distributed.VOLUME OF PRODUCT IN COMMERCE1 unit.DISTRIBUTIONMI.

_______________________________PRODUCTPlatelets. Recall # B-0382-5.CODEnit 0602748.RECALLING FIRM/MANUFACTURERLifeShare, Inc., Elyria, OH, by letter dated June 23, 2004.Firm initiated recall is complete.REASONBlood product, which was manufactured from a whole blood unit in which the associated red blood cells was found to contain clots, was distributed.VOLUME OF PRODUCT IN COMMERCE1 unit.DISTRIBUTIONOH.

_______________________________PRODUCTSource Plasma. Recall # B-0383-5.CODEUnit 03OWIC0313.RECALLING FIRM/MANUFACTURERBioLife Plasma Services, LP, Oshkosh, WI, by letter dated May 8, 2003. Firm initiated recall is complete.REASONBlood product, which was collected in a manner that may have compromised the sterility of the collection system, was distributed.VOLUME OF PRODUCT IN COMMERCE1 unit.DISTRIBUTIONMI.

_______________________________PRODUCTRed Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0391-5.CODEUnit 107589332 (split unit).RECALLING FIRM/MANUFACTURERBlood Systems, Inc., Scottsdale, AZ, by letter on September 27, 2004. Firm initiated recall is complete.REASONBlood products, which were collected from a donor with a history of multiple high risk behaviors, were distributed.VOLUME OF PRODUCT IN COMMERCE2 units,DISTRIBUTIONAZ.

_______________________________PRODUCTa) Platelets. Recall # B-0336-5;b) Fresh Frozen Plasma. Recall # B-0337-5.CODEa) and b) Unit number 6725887.RECALLING FIRM/MANUFACTURERBlood Center of New Jersey, Inc., East Orange, NJ, by telephone on May 16, 2003, and by letter on May 20, 2003. Firm initiated recall is complete.REASONBlood products, manufactured from a unit of Whole Blood that had a discrepant collection time, were distributed.VOLUME OF PRODUCT IN COMMERCE2 units.DISTRIBUTIONNJ, and NY.

_______________________________PRODUCTa) Red Blood Cells. Recall # B-0348-5;b) Cryoprecipitated AHF. Recall # B-0349-5;c) Plasma, Cryoprecipitate Reduced.Recall # B-0350-5.CODEa), b), and c) Unit number 1612234.RECALLING FIRM/MANUFACTURERBlood Center of New Jersey, Inc., East Orange, NJ, by facsimile and letter on April 1, 2003. Firm initiated recall is complete.REASONBlood products, collected from an ineligible donor due to a history of Idiopathic Thrombocytopenic Purpura (ITP), were distributed.VOLUME OF PRODUCT IN COMMERCE3 units.DISTRIBUTIONNJ, CA, and TN.

_______________________________PRODUCTPlatelets Pheresis, Leukocytes Reduced. Recall # B-0357-5.CODEUnit number 7796973.RECALLING FIRM/MANUFACTURERCentral Indiana Regional Blood Center, Indianapolis, IN, by telephone on September 30, 2004. Firm initiated recall is complete.REASONBlood product, that was labeled leukoreduced but there was insufficient documentation to confirm that the product was actually leukoreduced, was distributed.VOLUME OF PRODUCT IN COMMERCE1 unit.DISTRIBUTIONIN.

_______________________________PRODUCTRed Blood Cells Leukocytes Reduced. Recall # B-0385-5.CODEUnit 192514107.RECALLING FIRM/MANUFACTURERBlood Systems, Inc., Reno, NV, by telephone on May 22, 2002. Firminitiated recall is complete.REASONBlood product, which may have been stored at unacceptable temperatures, was distributed.VOLUME OF PRODUCT IN COMMERCE1 Unit.DISTRIBUTIONNV.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________PRODUCTIntinion 1.5 T MRI Scanner. Recall # Z-0272-05.CODESerial Numbers ZA101-ZA188, ZA190-192, ZA195, ZA200, ZA201.RECALLING FIRM/MANUFACTURERPhilips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter, dated April 17, 2003. Firm initiated recall is ongoing.REASONThere is a potential for the patient to be exposed to cryogenic fluids (liquid air) dripping from the vent during a quench due to the location of the vent.VOLUME OF PRODUCT IN COMMERCE172 units.DISTRIBUTIONNationwide and Internationally.